SELOKEN 100 mg Tablet

Зміст інструкції

1. SELOKEN 100 mg tablets
   1. What Seloken is and what it is used for
   2. What you need to know before taking Seloken
   3. Possible side effects
   4. How to store Seloken
   5. Contents of the pack and other information
2. SELOKEN 200 mg prolonged-release tablets
   1. What is Seloken and what is it used for
   2. What you need to know before taking Seloken
   3. Possible side effects
   4. How to store Seloken
   5. Contents of the pack and other information

SELOKEN 100 mg tablets

Metoprolol tartrate

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Seloken is and what it is used for
• 2. What you need to know before you take Seloken
• 3. How to take Seloken
• 4. Possible side effects
• 5. How to store Seloken
• 6. Contents of the pack and other information

1. What Seloken is and what it is used for

Seloken contains metoprolol tartrate. Metoprolol tartrate belongs to a group of medicines
called selective beta-blockers which work by slowing down the heartbeat and making the
heart beat with less force.
Seloken is indicated in adultsfor:

• treating high blood pressure (arterial hypertension)
• treating and preventing angina pectoris attacks (heart disease that manifests with chest pain)
• treating irregular heartbeat (arrhythmias, except for bradyarrhythmias)
• treating a heart attack (acute myocardial infarction)
• treating hyperthyroidism (syndrome caused by excessive hormone production).

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Seloken

Do not take Seloken

• if you are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same group (beta-blockers);
• if you have defects in the conduction of the heart (atrioventricular block of II or III degree);
• if the function of your heart is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you are being treated with medicines belonging to the group of beta-receptor agonists;
• if you have a condition in which the heartbeat is slowed (clinically relevant sinus bradycardia);
• if you have severe circulatory disorders of the limbs and suffer from severe forms of Raynaud's phenomenon (symmetric circulatory disorders affecting the fingers, often triggered by cold, with numbness, bluish skin and pain);
• if you suffer from a heart disease called "sick sinus syndrome" that affects the area where the heartbeat originates (unless a permanent pacemaker has been implanted);
• in case of cardiogenic shock (a heart condition that occurs when blood is not adequately pumped by the heart throughout the body);
• if you suffer from severe kidney disorders (severe renal failure);
• if you suffer from severe forms of asthma and chronic conditions affecting the bronchi and lungs, with congestion;
• if you suffer from low blood pressure (hypotension);
• if your doctor has diagnosed you with abnormally high levels of acid in your blood (metabolic acidosis);
• if you suffer from a tumor called "pheochromocytoma" that is not being treated (this tumor generally develops near a kidney and can cause high blood pressure).

If you are in any of the above situations, tell your doctor.
Seloken must notbe administered:

• to patients with suspected ongoing heart attack;
• to children and adolescents (see section “Children and adolescents”);
• in combination with intravenous therapy with verapamil or diltiazem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Seloken:

• if you have problems with the airways;
• if you suffer from asthma and chronic conditions affecting the bronchi and lungs, with congestion;
• if you have a type of chest pain called Prinzmetal's angina;
• if you have diabetes, a disease characterized by an excess of sugars in the blood;
• if the function of your heart is insufficient (heart failure);
• if you suffer from conduction disorders of the heart (moderate degree of atrioventricular conduction disturbance) as Seloken may worsen the disease leading to atrioventricular block;
• if you have problems with blood circulation (e.g. Raynaud's disease or other circulatory disorders of the limbs);
• if you are going to undergo surgery for non-cardiac reasons;
• if you suffer from a tumor called "pheochromocytoma" that is being treated. In this case, your doctor will prescribe you appropriate therapy at the same time;
• if you are taking a calcium antagonist (especially verapamil), another medicine for the treatment of high blood pressure, especially if administered by intravenous injection;
• if you suffer from or suspect you have problems with the thyroid gland (thyrotoxicosis), as Seloken may mask its symptoms;
• if you have severe liver problems (hepatic cirrhosis);
• if you suffer from or have ever suffered from skin rashes, including psoriasis, as Seloken may worsen it;
• if you suffer from dry eyes. Consult your doctor if any of these conditions are relevant to your case or have been in the past.

You should never stop treatment with Seloken suddenly, as this may worsen
heart problems. Talk to your doctor, who will tell you how to gradually stop therapy and
if necessary, will keep you under close observation.

Reduced heart rate (number of heartbeats per minute)
During treatment with Seloken, a reduction in heart rate may occur, i.e. a
slowing of the heartbeat (see section “Possible side effects”). If this happens, consult your
doctor, who will decide whether to reduce your dosage or gradually discontinue therapy.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
Seloken and, in particular, the anesthesiologist (the doctor responsible for anesthesia) in case of
surgery. Do not stop therapy before surgery. If the doctor deems it necessary
to stop therapy with Seloken, this will be done gradually.

Diabetes or hypoglycemia (low blood sugar levels)
If you suffer from diabetes and are being treated with medicines to treat diabetes (see section “Other medicines
and Seloken”), this medicine may interfere with sugar metabolism or mask the signs and
symptoms of hypoglycemia, in particular the accelerated heartbeat (tachycardia).

Allergic reactions
In patients treated with beta-blockers, allergic reactions take a more severe form and
are more difficult to treat (they may resist normal doses of adrenaline).

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still
result in positive doping tests.

Elderly
If you are elderly, use this medicine with caution as it may cause an excessive reduction in
blood pressure or heart rate, which may lead to serious circulatory problems.

Children and adolescents
Seloken must notbe administered to children and adolescents under 18 years of age.

Other medicines and Seloken
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines used when the heartbeat is irregular (antiarrhythmics such as quinidine and amiodarone)
• medicines that block the activity of histamine (antihistamines)
• antidepressants, drugs used to treat depression (such as, for example, monoamine oxidase inhibitors (MAOIs))
• antipsychotics, medicines for the treatment of some psychiatric disorders
• rifampicin (medicine to treat infections)
• hydralazine (medicine to treat high blood pressure)
• medicines that have an effect on the peripheral nervous system (drugs that block sympathetic ganglia)
• other beta-blockers (e.g. eye drops)
• clonidine (medicine to treat high blood pressure or prevent migraine). If you are taking clonidine and Seloken together, do not stop treatment with clonidine or Seloken without first consulting your doctor
• medicines for the treatment of high blood pressure or chest pain, called calcium antagonists (especially verapamil or diltiazem). (See section “Warnings and precautions”)
• medicines for the treatment of high blood pressure, called dihydropyridines (such as nifedipine and amlodipine)
• digoxin (medicine used for heart disorders)
• nitroglycerin (medicine used to treat some heart disorders)
• anesthetic medicines administered by inhalation
• indomethacin or ibuprofen or other medicines for pain and inflammation (NSAIDs)
• adrenaline or noradrenaline (medicines that increase blood pressure, usually used for the treatment of emergency allergic reactions)
• medicines used to treat diabetes taken by mouth (oral antidiabetics)
• lidocaine (used for the treatment of heart rhythm disturbances)
• ergot alkaloids (medicines used for migraine)
• tricyclic antidepressants, barbiturates and phenothiazines (medicines used for depression and psychiatric disorders that can lower blood pressure).

Seloken and alcohol
Tell your doctor if you drink alcohol, as this substance may increase the effect of Seloken.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
This medicine must notbe administered during pregnancy and breastfeeding unless
strictly necessary. Beta-blockers, including metoprolol, can cause harm to the fetus and early
abortion.
If treated with Seloken during pregnancy, your doctor will prescribe you the lowest possible dose
and will ask you to stop therapy at least 2 or 3 days before delivery, to avoid effects
in the newborn.
Children born to mothers who have taken Seloken before delivery or during breastfeeding may
be at risk of side effects including bradycardia (slowing of the heartbeat) and
hypoglycemia (low blood sugar levels).

Driving and using machines
Patients must know their reaction to Seloken before driving or using machines, as
dizziness and fatigue may occur. If you experience these symptoms, it is advisable not to
carry out these activities.

Seloken contains lactose(milk sugar)
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

Seloken contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3How to take Seloken
Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.
The doctor will tell you how many tablets to take each day and when, depending on your illness.
The tablets should be taken on an empty stomach.

Adults

High blood pressure (arterial hypertension)
The recommended dose is 1-2 tablets a day, in a single dose in the morning or
one tablet in the morning and one in the evening.

Angina pectoris
The recommended dose is 1-3 tablets a day divided into 2-3 doses.

Acute myocardial infarction
The recommended dose is 2 tablets a day divided into 2 doses.

Cardiac arrhythmias (excluding bradyarrhythmias)
The recommended dose is 1-2 tablets a day divided into 2-3 doses.

Hyperthyroidism
The recommended dose is 1 and a half/2 tablets a day divided into 3-4
doses.

If you have severe liver problems
If you suffer from severe liver problems, your doctor may decide to prescribe you a lower dose of Seloken.

Use in the elderly
If you are elderly, this medicine will be prescribed to you with caution due to the greater likelihood of
side effects. In particular, the doctor will regularly check your blood pressure and
heart rate (see “Warnings and precautions”).

Use in children and adolescents
Seloken must notbe administered to children and adolescents under 18 years of age.

If you take more Seloken than you should
In case of accidental ingestion/intake of an excessive dose of Seloken, immediately inform
your doctor or go to the nearest hospital.
In hospital you will be subjected to appropriate intervention protocols (e.g. gastric lavage,
administration of activated charcoal).

Symptoms of Seloken overdose may include: slowing of the heartbeat
(bradycardia and bradyarrhythmia), lowering of blood pressure (hypotension), heart failure, disturbances in the electrical conduction of the heart, atrioventricular block, cardiogenic shock
(a condition that occurs when blood is not adequately pumped by the heart throughout the body),
cardiac arrest, altered state of consciousness/coma, nausea, vomiting, severe circulatory disturbance characterized by bluish discoloration of the skin (cyanosis) and obstruction of the bronchi
due to contraction of the muscles around the airways (bronchospasm).

If you forget to take Seloken
Do not take a double dose to make up for the missed tablet.

If you stop taking Seloken
Improvement of your health condition should not lead to interruption of treatment unless
requested by your doctor.
Interruption of treatment must occur gradually, and under strict medical supervision.
In most patients, treatment can be discontinued in 14 days, decreasing the daily dose
gradually to reach the final dose of 25 mg of metoprolol once a
day.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During treatment with Seloken, as with any medicine, the following side effects may occur with the following frequency:

Very common (may affect more than 1 in 10 people)

• fatigue
• general weakness (asthenia).

Common (may affect up to 1 in 10 people)

• slowed heartbeat
• low blood pressure after suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension) with the possibility of loss of consciousness
• feeling of coldness in hands and feet
• increased awareness of heartbeat (palpitations)
• dizziness, headache
• nausea, abdominal pain, diarrhea, constipation
• shortness of breath during exertion.

Uncommon (may affect up to 1 in 100 people)

• worsening of heart failure symptoms (a condition in which the heart cannot pump enough blood to meet the body's needs), cardiogenic shock (a condition that occurs when blood is not adequately pumped by the heart throughout the body) in patients with heart attack, first-degree atrioventricular block, chest pain
• swelling and pain (edema)
• altered sensitivity such as tingling in the hands or feet (paresthesia)
• muscle cramps
• vomiting
• weight gain
• depression, difficulty concentrating, drowsiness or insomnia, nightmares
• skin rash (in the form of urticaria and psoriasiform lesions)
• increased sweating
• difficulty breathing.

Rare (may affect up to 1 in 1000 people)

• irregular heartbeat (cardiac arrhythmias)
• heart failure
• cardiac conduction disorders
• tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon)
• worsening of symptoms in patients with intermittent claudication due to blood circulation problems
• dry mouth
• alteration of blood tests related to liver function (transaminases)
• positive ANA test (positive anti-nuclear antibodies), associated with various autoimmune diseases (e.g. lupus)
• nervousness, anxiety
• erectile dysfunction, decreased sexual desire
• inflammation of the nasal mucosa (rhinitis)
• dry eyes, visual disturbances, eye inflammation (conjunctivitis)
• hair loss.

Very rare (may affect up to 1 in 10000 people)

• death of parts of tissues or organs (gangrene) in patients with pre-existing severe peripheral blood circulation disorders
• taste disorders
• reduction in the number of platelets in the blood (thrombocytopenia)
• liver disease (hepatitis)
• joint pain (arthralgia)
• memory disorders (including amnesia), confusion, hallucinations
• ringing in the ears (tinnitus)
• allergic reactions to sunlight
• worsening of a skin condition called “psoriasis”
• formation of a mass in the back of the abdomen (retroperitoneal fibrosis)
• abnormal curvature of the penis (Peyronie's disease).

Medicines like Seloken (beta-blockers) can mask the signs of thyroid problems
(thyrotoxicosis) and low blood sugar levels (hypoglycemia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can contribute to providing more information on the safety of
this medicine.

5. How to store Seloken

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 25°C.
• Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Seloken contains

• The active ingredient is: metoprolol tartrate 100 mg.
• The other ingredients are: carboxymethylamido sodiumA (see paragraph “Seloken contains sodium”), lactose(see paragraph “Seloken contains lactose”), anhydrous colloidal silica, povidone, magnesium stearate, microcrystalline cellulose.

Description of the appearance of Seloken and contents of the pack
Seloken 100 mg tablets are white to off-white, circular, with a score line and with
“A/mE” imprinted on one side.
The tablet can be divided into equal parts by breaking it along the score line.
The pack contains 50 tablets.

Marketing authorisation holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milano.

Distributor for sales: INNOVA PHARMA S.p.A. - Via Matteo Civitali, 1 - 20148 Milano.

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje – Sweden
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milano – Italy
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia – Italy

SELOKEN 200 mg prolonged-release tablets

Metoprolol tartrate

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Seloken is and what it is used for
• 2. What you need to know before you take Seloken
• 3. How to take Seloken
• 4. Possible side effects
• 5. How to store Seloken
• 6. Contents of the pack and other information

1. What is Seloken and what is it used for

Seloken contains metoprolol tartrate. Metoprolol tartrate belongs to a group of medicines
called selective beta-blockers which work by slowing the heartbeat and making the
heart beat with less force.
Seloken is indicated in adultsfor:

• treating high blood pressure (arterial hypertension);
• treating and preventing angina pectoris attacks (heart disease that manifests with chest pain).

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Seloken

Do not take Seloken

• if you are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines belonging to the same group (beta-blockers);
• if you have defects in the conduction of the heart (second or third degree atrioventricular block);
• if the function of your heart is insufficient to ensure adequate blood supply to the body (decompensated heart failure);
• if you are being treated with medicines belonging to the group of beta-receptor agonists;
• if you have a condition in which the heartbeats are slowed (clinically relevant sinus bradycardia);
• if you have severe circulatory disorders in the limbs and suffer from severe forms of Raynaud's phenomenon (symmetric circulatory disorders affecting the fingers, often triggered by cold, with numbness, bluish skin and pain);
• if you suffer from a heart disease called “sick sinus syndrome” that affects the area where the heartbeat originates (unless a permanent pacemaker has been implanted);
• in case of cardiogenic shock (a heart disorder that occurs when blood is not adequately pumped by the heart throughout the body);
• if you suffer from severe kidney disorders (severe renal failure);
• if you suffer from severe forms of asthma and chronic conditions affecting the bronchi and lungs, with congestion;
• if you suffer from low blood pressure (hypotension);
• if your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis);
• if you suffer from a tumor called “pheochromocytoma” that is not being treated (this tumor usually develops near a kidney and can cause high blood pressure).

If you are in any of the above situations, tell your doctor.
Seloken must notbe administered:

• in patients with suspected ongoing heart attack;
• to children and adolescents (see section “Children and adolescents”);
• in combination with intravenous therapy with verapamil or diltiazem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Seloken:

• if you have problems with the airways;
• if you suffer from asthma and chronic conditions affecting the bronchi and lungs, with congestion;
• if you have a type of chest pain called Prinzmetal's angina;
• if you have diabetes, a disease characterized by an excess of sugars in the blood;
• if the function of your heart is insufficient (heart failure);
• if you suffer from conduction disorders of the heart (moderate degree disturbance of atrioventricular conduction) as Seloken may worsen the disease leading to atrioventricular block;
• if you have problems with blood circulation (e.g. Raynaud's disease or other circulatory disorders in the limbs);
• if you are going to undergo surgery for non-cardiac reasons;
• if you suffer from a tumor called “pheochromocytoma” that is being treated. In this case, your doctor will prescribe adequate therapy at the same time;
• if you are taking a calcium antagonist (especially verapamil), another medicine for the treatment of high blood pressure, especially if administered by intravenous injection;
• if you suffer from or suspect you have problems with the thyroid gland (thyrotoxicosis), as Seloken may mask its symptoms;
• if you have severe liver problems (hepatic cirrhosis);
• if you suffer from or have ever suffered from skin rashes, including psoriasis, as Seloken may worsen them;
• if you suffer from dry eyes. Consult your doctor if any of these conditions are relevant to your case or have been in the past.

You should never stop treatment with Seloken suddenly, as this may worsen
heart problems. Talk to your doctor, who will tell you how to gradually stop therapy and
may keep you under close observation.

Reduced heart rate (number of heartbeats per minute)
During treatment with Seloken, a reduction in heart rate may occur, i.e. a
slowing of the heartbeat (see section “Possible side effects”). In this case, consult your
doctor, who will decide whether to reduce your dose or gradually stop therapy.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
Seloken and, in particular, the anesthesiologist (the doctor responsible for anesthesia) in case of
surgery. Do not stop therapy before surgery. If the doctor deems it necessary
to stop therapy with Seloken, this will be done gradually.

Diabetes or hypoglycemia (low blood sugar levels)
If you suffer from diabetes and are being treated with medicines to treat diabetes (see section “Other medicines
and Seloken”), this medicine may interfere with sugar metabolism or mask the signs and
symptoms of hypoglycemia, in particular accelerated heartbeats (tachycardia).

Allergic reactions
In patients treated with beta-blockers, allergic reactions take a more severe form and
are more difficult to treat (they may resist normal doses of adrenaline).

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still
result in positive doping tests.

Elderly
If you are elderly, use this medicine with caution as it may cause an excessive reduction in
blood pressure or heart rate, which may lead to serious circulatory problems.

Children and adolescents
Seloken must notbe administered to children and adolescents under the age of 18 years.

Other medicines and Seloken
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines used when the heartbeat is irregular (antiarrhythmics such as quinidine and amiodarone)
• medicines that block the activity of histamine (antihistamines)
• antidepressants, medicines used to treat depression (such as, for example, monoamine oxidase inhibitors (MAOIs))
• antipsychotics, medicines for the treatment of some psychiatric disorders
• rifampicin (medicine for treating infections)
• hydralazine (medicine for treating high blood pressure)
• medicines that have an effect on the peripheral nervous system (drugs that block sympathetic ganglia)
• other beta-blockers (e.g. eye drops)
• clonidine (medicine for treating high blood pressure or preventing migraine). If you are taking clonidine and Seloken together, do not stop treatment with clonidine or Seloken without first consulting your doctor
• medicines for the treatment of high blood pressure or chest pain, called calcium antagonists (especially verapamil or diltiazem). (See section “Warnings and precautions”)
• medicines for the treatment of high blood pressure, called dihydropyridines (such as nifedipine and amlodipine)
• digoxin (medicine used for heart disorders)
• nitroglycerin (medicine used to treat some heart disorders)
• anesthetic medicines administered by inhalation
• indomethacin or ibuprofen or other medicines for pain and inflammation (NSAIDs)
• adrenaline or noradrenaline (medicines that increase blood pressure, usually used for the treatment of emergency allergic reactions)
• medicines used to treat diabetes administered orally (oral antidiabetics)
• lidocaine (used for the treatment of heart rhythm disturbances)
• ergot alkaloids (medicines used for migraine)
• tricyclic antidepressants, barbiturates and phenothiazines (medicines used for depression and psychiatric disorders that can lower blood pressure).

Seloken and alcohol
Tell your doctor if you drink alcohol, as this substance may increase the effect of Seloken.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
This medicine must notbe administered during pregnancy and breastfeeding unless
strictly necessary. Beta-blockers, including metoprolol, can cause harm to the fetus and early
miscarriage.
If treated with Seloken during pregnancy, your doctor will prescribe the lowest possible dose
and ask you to stop therapy at least 2 or 3 days before delivery, to avoid effects
in the newborn.
Babies born to mothers who have taken Seloken before delivery or during breastfeeding may
be at risk of side effects including bradycardia (slowed heart rate) and
hypoglycemia (low blood sugar levels).

Driving and using machines
Patients must be aware of their reaction to Seloken before driving or using machines, as
dizziness and fatigue may occur. If you experience these symptoms, it is advisable not to
carry out these activities.

Seloken contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release tablet, i.e.
essentially ‘sodium-free’.

3How to take Seloken
Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts ask your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when depending on your illness.
The prolonged-release tablets (whole or halved) must be taken on an empty stomach with
a little water, without chewing or crushing them.

Adults

High blood pressure (hypertension)
The recommended dose is 100-200 mg per day, in a single dose in the morning.

Angina pectoris
The recommended dose is 100-200 mg per day in a single dose in the morning.

If you have severe liver problems
If you suffer from severe liver problems, your doctor may decide to prescribe a lower dose of Seloken.

Use in the elderly
If you are elderly, this medicine will be prescribed to you with caution due to the greater likelihood of
side effects. In particular, the doctor will regularly check your blood pressure and
heart rate (see “Warnings and precautions”).

Use in children and adolescents
Seloken must notbe administered to children and adolescents under the age of 18 years.

If you take more Seloken than you should
In case of accidental ingestion/taking of an excessive dose of Seloken, immediately inform
your doctor or go to the nearest hospital.
In hospital you will be subjected to appropriate intervention protocols (e.g. gastric lavage,
administration of activated charcoal).

Symptoms of Seloken overdose may include: slowed heartbeat
(bradycardia and bradyarrhythmia), lowering of blood pressure (hypotension), heart failure,
electrical conduction disturbances of the heart, atrioventricular block, cardiogenic shock
(disorder that occurs when blood is not adequately pumped by the heart throughout the body),
cardiac arrest, altered state of consciousness/coma, nausea, vomiting, severe disturbance of
blood circulation characterized by bluish discoloration of the skin (cyanosis) and obstruction of the bronchi
due to contraction of the muscles around the airways (bronchospasm).

If you forget to take Seloken
Do not take a double dose to make up for a missed tablet.

If you stop taking Seloken
Improvement of your health condition should not lead to interruption of treatment unless
requested by your doctor.
Interruption of treatment must occur gradually, and under close medical supervision.
In most patients, treatment can be discontinued in 14 days, decreasing the daily dose
gradually until reaching the final dose of 25 mg of metoprolol once a
day.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Seloken, as with any medicine, the following side effects may occur with the following frequency:

Very common (may affect more than 1 in 10 people)

• fatigue;
• general weakness (asthenia).

Common (may affect up to 1 in 10 people)

• slowed heartbeat;
• low blood pressure when moving quickly from a sitting or lying position to an upright position (orthostatic hypotension) with possible loss of consciousness;
• coldness in hands and feet;
• increased awareness of heartbeat (palpitations);
• dizziness, headache;
• nausea, abdominal pain, diarrhoea, constipation;
• shortness of breath during exertion.

Uncommon (may affect up to 1 in 100 people)

• worsening of heart failure symptoms (a condition in which the heart is unable to pump enough blood to meet the body's needs), cardiogenic shock (a condition that occurs when blood is not adequately pumped by the heart throughout the body) in patients with a heart attack, first-degree atrioventricular block, chest pain;
• swelling and pain (edema);
• altered sensation such as tingling in the hands or feet (paresthesia);
• muscle cramps;
• vomiting;
• weight gain;
• depression, difficulty concentrating, drowsiness or insomnia, nightmares;
• skin rash (in the form of urticaria and psoriasiform lesions);
• increased sweating;
• difficulty breathing.

Rare (may affect up to 1 in 1000 people)

• irregular heartbeat (cardiac arrhythmias);
• heart failure;
• disturbances of cardiac conduction;
• tingling and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• worsening of symptoms in patients with intermittent claudication due to circulatory problems;
• dry mouth;
• changes in blood tests related to liver function (transaminases);
• positive ANA test (positive anti-nuclear antibodies), associated with various autoimmune diseases (e.g. lupus);
• nervousness, anxiety;
• erectile dysfunction, decreased libido;
• inflammation of the nasal mucosa (rhinitis);
• dry eyes, visual disturbances, eye inflammation (conjunctivitis);
• hair loss.

Very rare (may affect up to 1 in 10000 people)

• death of parts of tissues or organs (gangrene) in patients with pre-existing severe peripheral blood circulation disorders;
• taste disturbances;
• reduced number of platelets in the blood (thrombocytopenia);
• liver disease (hepatitis);
• joint pain (arthralgia);
• memory problems (including amnesia), confusion, hallucinations;
• ringing in the ears (tinnitus);
• allergic reactions to sunlight;
• worsening of a skin condition called “psoriasis”;
• formation of a mass in the back of the abdomen (retroperitoneal fibrosis);
• abnormal curvature of the penis (Peyronie's disease).

Medicines like Seloken (beta-blockers) can mask the signs of thyroid problems
(thyrotoxicosis) and low blood sugar levels (hypoglycemia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Seloken

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 25°C.
• Do not use this medicine after the expiry date which is stated on the package after SCAD. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Seloken contains

• The active ingredient is: metoprolol tartrate 200 mg.
• The other ingredients are: aluminosilicate of sodium(see section “Seloken contains sodium”), solid paraffin, ethylcellulose, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol
• 6000.

Description of the appearance of Seloken and contents of the pack
Seloken 200 mg prolonged-release tablet is from white to off-white, oval-shaped, with a breaking notch on both sides and imprinted with “A/mD” on one side.
The breaking notch on the tablet is to facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.
The pack contains 28 prolonged-release tablets.

Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 - 20148 Milan.

Distributor for sale: INNOVA PHARMA S.p.A. - Via Matteo Civitali, 1 - 20148 Milan.

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje – Sweden
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan – Italy
Savio Industrial S.r.l.
Via Emilia, 21
27100 Pavia – Italy